FDA Pre-Submission Program Presentation

FDA issued a final version of its guidance “Requests for Feedback on Medical Device Submissions:The Pre-Submission Program and Meetings with Food and Drug Administration Staff”. The document is dated Feb 18, 2014. The link provided contains slides from a presentation by Soma Kalb from FDA’s Offiice of Device Evaluation and Elizabeth Hillebrenner from FDA’s Office of In Vitro Diagnostics and Radiological Health.

Keyword: Presub.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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